Status:
UNKNOWN
PEERS Multicenter Osseospeed TM TX Profile Implant: German Astra Soft Tissue (GAST) Maintenance Study
Lead Sponsor:
Johannes Gutenberg University Mainz
Collaborating Sponsors:
Dentsply Sirona Implants and Consumables
Conditions:
Inclined Atrophy of the Distal Mandible
Socket Like Atrophy of the Aesthetic Zone
Eligibility:
All Genders
18+ years
Brief Summary
The open, prospective, non-controlled observational study is designed to provide information on the short-, medium- and long-term clinical performance of the Astra Tech OsseospeedTM implant surface in...
Detailed Description
Within the new OsseoSpeedTM TX Profile Implant from Astra Tech a special surface modification treated with diluted hydrofluoric acid is combined with an inclined implant-abutment interface to support ...
Eligibility Criteria
Inclusion
- loss of tooth aesthetic zone (a maximum of 4 implants)
- loss of tooth at the distal mandible (distal canine) (a maximum of 4 implants)
- presence of inclined alveolar ridge profile
- antagonists are natural teeth or fixed prosthesis
Exclusion
- \< 18 years
- Tumour or irradiation
- bisphosphonate or cortisone intake
- Diabetes mellitus
- Mental illness or disorder with affection of compliance
- Consumption of \> 20 cigarettes/day
- Bruxism
- Acute Mucosal infection or illness (e.g. acute Parodontitis, Pemphigus, Lichen)
- Relation of Crown to Implant ratio of \> 1
- No clinical primary stability of the implant after insertion
Key Trial Info
Start Date :
July 1 2011
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
July 1 2014
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT01400321
Start Date
July 1 2011
End Date
July 1 2014
Last Update
November 16 2012
Active Locations (28)
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1
Department of Oral and Maxillofacial Surgery, University Mainz, Medical Center
Mainz, Rhineland-Palatinate, Germany, 55131
2
MSc. E. Trilck
Berlin, Germany, D-10117
3
Dr.Dr. U. Schwarzott
Berlin, Germany, D-10969
4
Dr. M. Loeck
Berlin, Germany, D-14199